NCT00449917

Brief Summary

The purpose of this study is to determine the benefits of "Visiobiane Anti-age" dietary supplement on macular pigment optical density, contrast sensibility and visual acuity. Additionally, the study would like to evaluate seric variations of carotenoids and the total antioxydant capacity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

October 6, 2011

Status Verified

October 1, 2011

Enrollment Period

10 months

First QC Date

March 20, 2007

Last Update Submit

October 5, 2011

Conditions

Macular Pigment Optical Density

Keywords

visual caracteristicsmacular pigment optical densityvisual acuitycontrast sensibilityluteindocosahexaenoic acid (DHA)

Outcome Measures

Primary Outcomes (1)

  • macular pigment optical density

Secondary Outcomes (5)

  • contrast sensibility

  • visual acuity

  • seric carotenoids concentrations

  • total antioxidant capacity

  • influence of SR-B1 genetic polimorphism

Interventions

luteinDRUG
DHADRUG
vitaminsDRUG

Eligibility Criteria

Age45 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy caucasian men
  • age : 45-55
  • BMI \< 25

You may not qualify if:

  • non healthy
  • retinian and/or visual anomaly
  • Ocular media not clear enough to allow good fundus photography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRNH Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63009, France

Location

MeSH Terms

Interventions

LuteinVitamins

Intervention Hierarchy (Ancestors)

XanthophyllsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological FactorsMicronutrientsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesNutrientsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Franck Bacin, MD

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 20, 2007

First Posted

March 21, 2007

Study Start

September 1, 2006

Primary Completion

July 1, 2007

Study Completion

November 1, 2007

Last Updated

October 6, 2011

Record last verified: 2011-10

Locations

FR(1)